# K241433: EVE Synergy (EVE-20M)

- Pathway: 510(k) (Traditional)
- Applicant: Weero Co., Ltd.
- Decided: Jun 4, 2025 after 379 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K943450 (1995). 324 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 326 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210877: Evolve System with the T3 Applicator, InMode, Ltd. (2021) Summary page 5.
- K201285: InMode Evolve System with the Tone Applicator, InMode, Ltd. (2021) Summary page 5.

## Most influential descendants
- K253542: Apollo Quattro (APQ-10M) (2026), 0 descendants of its own

## Indications for use
EMS is used for: * Relaxation of muscle spasms * Prevention or retardation of disuse atrophy * Increasing local blood circulation * Muscle re-education * Maintaining or increasing range of motion * Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis TENS is used for: * Symptomatic relief and management of chronic, intractable pain * Post-surgical acute pain * Post-trauma acute pain

Source page: https://510kreport.com/device/K241433
Methodology: https://510kreport.com/methodology